PlainRecalls
FDA Drug Moderate Class II Terminated

S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.

Reported: November 13, 2019 Initiated: August 12, 2019 #D-0261-2020

Product Description

S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
10 50 ml vials
Distribution
Nationwide in the USA
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 10 50 ml vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0261-2020.